BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 12796515 · Received November 11, 2021

    Report

    Report Number
    0009617840-2021-00025
    Event Type
    Injury
    Date Received
    November 11, 2021
    Date of Event
    October 29, 2021
    Report Date
    April 28, 2022
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE IS THE SAME/SIMILAR TO 510(K) NUMBER K182964. G2: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN SINGAPORE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. UPDATED SECTIONS: B1, B2, B5, G2, G3, G6, H1, H2, H3, H6, H10. TECHNICAL REVIEW AND PHYSICAL EVALUATION: LOG FILES WERE REVIEWED BY A ZIMMER BIOMET SUBJECT MATTER EXPERT (SME). SME COULD NOT CONFIRM REPORTED EVENT WITH LOGS AND EVIDENCE PROVIDED. SME CONSIDERS THAT THE SHORT FILM X-RAYS PROVIDED ARE NOT AMENABLE TO EXTRACTION OF BONE MECHANICAL AXES FOR COMPARISONS WITH THE ROBOTIC SYSTEM. SME ALSO NOTES THAT TIBIAL PLATEAU LANDMARKS ACQUIRED INTRA OPERATIONALLY HAD POSITIONS DIFFERING SIGNIFICANTLY FROM EXPECTATIONS, WHEN COMPARED TO THEIR POSITIONS FOR A TYPICAL GENERIC BONE. THERE WERE NO SOFTWARE ANOMALIES OR DEFECTS IDENTIFIED DURING REVIEW OF THE LOGS THAT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ANALYSIS OF LOG FILES ASSOCIATED WITH THE REPORTED EVENT CONFIRMED THE PLANNED AND VALIDATED VALUES, BUT NOT THE VALUES COMING FROM X-RAYS. THE LOGS DO NOT CONTAIN INFORMATION REGARDING THE PRE-OPERATIVE AND POST-OPERATIVE X-RAYS MEASUREMENTS. WHICH INDICATE THE FEMUR TO TIBIA BONE TRACKER WAS ACCURATE AT THE BEGINNING AND THE END OF THE SURGERY. THE PRE-OP XRAYS THAT THE REFERENCE POINT TAKEN TO CALCULATE THE AMOUNT OF RESECTION WERE POSITIONED VERY EXTERNAL ON EACH PLATEAU. THE VALIDATED RESECTED VALUES WERE MADE ACCORDING TO PLAN. THE USER OBSERVED ON THE FINAL XRAYS THAT THE KNEE REMAINED IN A MORE PRONOUNCED VARUS. AS THE AMOUNT OF BONE RESECTED ARE COMPUTED AT THE LANDMARK POSITIONING, THE LANDMARKING ANALYZED REVEALED: - THE TIBIA MEDIAL PLATEAU LANDMARK WAS TAKEN VERY CLOSE TO THE CENTER. THE GAP WOULD BE UNDER-ESTIMATED BY THE SYSTEM. THIS IS CONFIRMED BY THE INITIAL MEDIAL FLEXION GAP REMAINING AT 0MM. DURING PREVENTIVE MAINTENANCE PERFORMED BY FSE ON JAN 18, 2022, FSE VERIFIED AND TESTED AS PER PROCEDURE THE UNIT PASSED ALL TESTS. ROBOT SYSTEM WAS FUNCTIONAL AS INTENDED. DHR REVIEW REVIEW OF THE DHR IDENTIFIED NO DEVIATION AND/OR ANOMALIES RELATED TO THE REPORTED COMPLAINT EVENT. COMPLAINT HISTORY REVIEW A COMPLAINT HISTORY REVIEW WAS CONDUCTED. THE SEARCH IDENTIFIED ONE (1) ADDITIONAL COMPLAINT FOR THE SAME SERIAL NUMBER, WITH SIMILAR OR SAME ISSUE. THE SEARCH IDENTIFIED SEVEN (7) ADDITIONAL COMPLAINTS REPORTED FOR THE SAME PART NUMBER WITHIN ONE (1) YEAR PRIOR TO THE NOTIFICATION DATE OF THIS COMPLAINT (OCT 31, 2021) AND THEREAFTER FOR THE SAME OR SIMILAR ISSUE. ROOT CAUSE: REPORTED EVENTS COULD NOT BE CONFIRMED AND A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE IS THE SAME/ SIMILAR TO 510(K) NUMBER K182964. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROBOTIC INSTRUMENTATION THE SURGEON PLANNED FOR TIBIA 0 DEGREE V/V CUT BUT ENDED UP IN 7 DEGREE VARUS (FROM POST-OP X-RAY). THE ROBOTIC SYSTEM SUGGESTED TIBIA BONE CUT OF 11.5MM ON LATERAL AND 9MM ON MEDIAL. THE VERIFIED CUT WAS 9MM MEDIAL AND 12MM LATERAL. VERIFICATION SHOWED 1 DEGREE OF VALGUS. FROM PRE-OP X-RAY TEMPLATING, SURGEON SHOULD HAVE CUT 12MM ON LATERAL AND 4MM ON MEDIAL TO GET THE KNEE STRAIGHT. NO MID SURGERY INTERVENTION OCCURRED. SURGEON EXECUTED THE SURGERY THAT WAS ORIGINALLY PLANNED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A TKA THAT THE SURGEON PLANNED FOR TIBIA 0 DEGREE V/V CUT BUT ENDED UP IN 7 DEGREE VARUS (FROM POST-OP X-RAY). ROSA SUGGESTED TIBIA BONE CUT OF 11.5MM ON LATERAL AND 9MM ON MEDIAL. THE VERIFIED CUT WAS 9MM MEDIAL AND 12MM LATERAL. ROSA VERIFICATION SHOWED 1 DEGREE OF VALGUS. FROM PRE-OP X-RAY TEMPLATING, SURGEON SHOULD HAVE CUT 12MM ON LATERAL AND 4MM ON MEDIAL TO GET THE KNEE STRAIGHT. NO MID SURGERY INTERVENTION OCCURRED. SURGEON EXECUTED THE SURGERY THAT WAS ORIGINALLY PLANNED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690947 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other